Njs Associates

Company Description NJS Associates Company is a biostatistics-led contract research organization (CRO) specializing in regulatory-ready biometrics support across Phase I–III clinical development. Founded in 2011 by experienced biostatisticians, the company partners with biotech and pharmaceutical sponsors on complex, high-stakes programs where statistical rigor and regulatory alignment are essential. NJS has supported over 100 clinical trials and more than 10 regulatory submissions, including NDA, BLA, and global filings. Integrated teams provide senior biostatistics leadership and statistical programming from study design through regulatory submission, with deep expertise in oncology, CNS, cardiovascular, rare disease, vaccines, and other complex indications. Sponsors engage NJS through flexible models including end-to-end CRO delivery, functional service provider (FSP) arrangements, and strategic biometrics staffing.

Role Description The Lead Statistical Programmer will oversee and execute statistical programming activities to support clinical trials and regulatory submissions. This contract position is based on-site in San Francisco, CA, and involves leading programming teams, coordinating timelines, and ensuring high-quality deliverables in accordance with sponsor requirements, SOPs, and regulatory standards. Day-to-day responsibilities include developing and validating SDTM and ADaM datasets, creating TLFs (tables, listings, and figures), reviewing statistical analysis plans, and collaborating closely with biostatisticians, data managers, and clinical teams. The role also includes supervising programming workflows, implementing quality control checks, contributing to process improvements, and supporting responses to regulatory queries. The Lead Statistical Programmer will serve as a technical expert, mentor team members, and help ensure consistency and efficiency across projects.

Qualifications

• Strong proficiency in statistical programming in the Pharmaceutical or Biotech industry (e.g., SAS, R) and experience with CDISC standards, including SDTM and ADaM.
• Demonstrated experience leading programming activities for Phase I–III clinical studies and contributing to NDA, BLA, or other regulatory submissions.
• Solid understanding of biostatistics concepts, clinical trial design, and regulatory guidelines (e.g., ICH, FDA, EMA) relevant to statistical programming.
• Experience collaborating with cross-functional teams, including biostatistics, data management, clinical operations, and regulatory affairs.
• Proven ability to manage multiple projects, set priorities, and meet timelines in a fast-paced, high-complexity environment.
• Strong problem-solving skills, attention to detail, and commitment to data integrity and quality assurance.
• Effective written and verbal communication skills, including the ability to document programming specifications and present technical information clearly.
• Bachelor’s or Master’s degree in statistics, biostatistics, mathematics, computer science, or a